After a short general survey about 'Good Manufacturing Practice ( gmp )' the interpretation of gmp rules in the pharmaceutical industry is illustrated by giving a few practical examples. Finally some thoughts are developed on how these rules can also be used in hospital pharmacy....
The “c” is added to certify that every step used in producing a product was not only done under the guidelines of GMP, but also that every step was finished in the most current manner available. GMP rules and regulations are constantly improving and updating with technology. Because the ...
A Abdellah,MI Noordin,WAW Ismail - 《Saudi Pharmaceutical Journal Spj the Official Publication of the Saudi Pharmaceutical Society》 被引量: 9发表: 2015年 [Good Manufacturing Practice (GMP) in the food industry] The -Rules, which were formulated by the WHO in 1969, were passed into German ...
欧盟GMP中英对照版1-9章T-Make.doc,欧盟GMP 欧盟人与兽用药品生产质量管理规范汇编 EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 欧盟药事法规第4卷 GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS 药品GMP指南 第 0部
GMP 欧盟GMP中英对照第一部分1-9章+原料药基本要求1/98 欧盟人与兽用药品生产质量管理规范汇编 EudraLex TheRulesGoverningMedicinalProductsintheEuropeanUnion Volume4 欧盟药事法规第4卷 GUIDETOGOODMANUFACTURINGPRACTICEFOR MEDICINALPRODUCTS 药品GMP指南 第0部分-简介(2008) 文件历史日期 发行本指南第一版,其包括一...
in pharmaceutical manufacturing. The object of the GMP and associated rules is the assurance of the quality of the products for the safety, well being and protection of the patient. In achieving this aim it is impossible to over-emphasise the importance of people, at al... RH Shaikh,AA ...
GMP rules and guidelines are developed by regulatory agencies that oversee their regions, and include Health Canada, the US Food and Drug Administration (FDA) and the World Health Organization (WHO). While the principles of GMP are universal, each agency may have specific requirements and guideline...
The European Union has developed a single market through a standardized system of laws that apply in all its Member States. The same rules and harmonized procedures apply to all the 28 Member States regarding the authorization of medicines and the supervision of safety of medicines. The EU Regula...
(52pages,includingfiveappendices) waspublishedin1977.Athirdedition(110pages,fiveappendices)waspublishedin1983 (Lund,1994).Subsequently,the2002editionofRulesandGuidanceforPharmaceutical ManufacturersandDistributors,commonlyknownasthe'OrangeGuide',waspublished withmanychangesandadditionstothedetailedEuropeanCommunity...